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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005178-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study is intended to investigate the pharmacodynamic drug-drug interaction as well as the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat + isosorbite mononitrate | Experimental | Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each,prior to start of vericiguat administration. Then subjects received 2.5 mg vericiguat for about 14 days, followed by 5 mg vericiguat for about 14 days, followed by 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days). |
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| Placebo + isosorbite mononitrate | Placebo Comparator | Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration. Then subjects received placebo matching 2.5 mg vericiguat for about 14 days, followed by placebo matching 5 mg vericiguat for about 14 days, followed by placebo matching 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat (BAY1021189) | Drug | 2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Regular measurements of blood pressure after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration. | Up to 8 weeks |
| Heart rate | Regular measurements heart rate after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to 9 weeks |
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Inclusion Criteria:
Patients with stable CAD defined by
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsherzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Baden-Wurttemberg | 79189 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35299288 | Derived | Boettcher M, Mikus G, Trenk D, Dungen HD, Donath F, Werner N, Karakas M, Besche N, Schulz-Burck D, Gerrits M, Hung J, Becker C. Vericiguat in combination with isosorbide mononitrate in patients with chronic coronary syndromes: The randomized, phase Ib, VISOR study. Clin Transl Sci. 2022 May;15(5):1204-1214. doi: 10.1111/cts.13238. Epub 2022 Mar 17. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
| C030397 | isosorbide-5-mononitrate |
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| Placebo | Drug | Matching placebo |
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| Isosorbide mononitrate (ISMN) | Drug | 30 mg/tablet or 60 mg/tablet |
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| Universitätsklinikum Heidelberg |
| Heidelberg |
| Baden-Wurttemberg |
| 69120 |
| Germany |
| Medizinische Einrichtungen der Universität Bonn | Bonn | North Rhine-Westphalia | 53105 | Germany |
| SocraTec R&D GmbH | Erfurt | Thuringia | 99084 | Germany |
| Charité - Campus Virchow-Klinikum (CVK) | Berlin | 13353 | Germany |
| Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg | 20246 | Germany |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |